A panel of 65 global experts has identified eight clinical standards for the management of adverse effects during treatment for tuberculosis (TB).
Adverse effects to TB treatment can lead to morbidity, mortality, and treatment interruption. In collaboration with the panel representing major societies, associations, and groups active in the TB field, the authors of the study assessed the available evidence on Adverse Effects (AE).
The clinical standards, released on 01 July 2023 titled “Clinical standards for the management of adverse effects during treatment for TB,” were published in the International Journal of Tuberculosis and Lung Disease (IJTLD), aim to promote best practices for the diagnosis and management of adverse effects.
“Adverse effects to TB treatment can be extremely dangerous and life-threatening. Therefore, it is important that our healthcare professionals are equipped with the latest guidance in order to respond quickly and effectively to any such event,” said John Paul Dongo, Director of The Union Uganda Office. “People with TB deserve the best possible care, which is why I’m so proud of The Union for leading this knowledge development exercise.”
Researchers invited 65/81 experts who participated in a Delphi process using a 5-point Likert scale to score draft standards. They identified eight clinical standards.
Each person commencing treatment for TB should: Standard 1, be counselled regarding AE before and during treatment; Standard 2, be evaluated for factors that might increase AE risk with regular review to actively identify and manage these; Standard 3, when AE occur, carefully assessed and possible allergic or hypersensitivity reactions considered; Standard 4, receive appropriate care to minimise morbidity and mortality associated with AE; Standard 5, be restarted on TB drugs after a serious AE according to a standardised protocol that includes active drug safety monitoring. In addition: Standard 6, healthcare workers should be trained on AE including how to counsel people undertaking TB treatment, as well as active AE monitoring and management; Standard 7, there should be active AE monitoring and reporting for all new TB drugs and regimens; and Standard 8, knowledge gaps identified from active AE monitoring should be systematically addressed through clinical research.
These clinical standards provide an approach that focuses on the individual and consensus-based methods to minimize the impact of adverse effects during TB treatment.
“The clinical standards are realistically applicable. However, a number of factors contribute to inadequate implementation of these standards,” said Dongo. “Some of these policies are already in place with this information, and regular revisions are also made to update the policies with the latest information.”
Limitation include: lack of adequate supervision and mentorship for healthcare workers, inadequate resources to carry out community sensitization/mobilization and patient follow-up, inadequate resources to carry the relevant investigations for adverse events, and poor referral network from the lower-level health facilities to tertiary institutions for proper management’s, he said.
“Other factors could be patient-related, including lack of transport to the health facility and patients’ ignorance about the adverse events. Through advocacy and addressing the above factors, it will be possible to implement the clinical standards at all levels,” said Dongo.
The International Journal of Tuberculosis and Lung Disease (IJTLD) is managed by the International Union Against Tuberculosis and Lung Disease (The Union).
In future issues of the IJTLD, additional clinical standards will be published, including “Clinical standards for drug-susceptible TB in children and adolescents” and “Clinical standards for the diagnosis and management of asthma in low-income and middle-income countries.”
More about the study here: https://www.ingentaconnect.com/contentone/iuatld/ijtld/2023/00000027/00000007/art00004